Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of different doses of rivaroxaban in elderly chinese patients with nonvalvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: from january 2023 to december 2025, 300 elderly patients with nonvalvular atrial fibrillation in drum tower hospital affiliated to medical scholl of nanjing university will be enrolled to compare the efficacy and safety of rivaroxaban-h, rivaroxaban-m and rivaroxaban-l dose in elderly patients after 24-month follow-up.

to explore the appropriate dose of rivaroxaban to prevent stroke in elderly chinese patients with nonvalvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy. from january 2023 to december 2025, 300 elderly patients with nonvalvular atrial fibrillation in drum tower hospital affiliated to medical scholl of nanjing university will be enrolled to compare the efficacy and safety of rivaroxaban-h, rivaroxaban-m and rivaroxaban-l dose in elderly patients after 24-month follow-up. the efficacy indexes include stroke, non-cns systemic embolism, fatal stroke, transient ischemic attack and myocardial infarction, and the safety indexes include major bleeding, non-major clinically relevant bleeding, minor bleeding events.

Eligibility criteria:
inclusion criteria: * age≥75 years * chinese patient: male or female * patients had to be diagnosed as nonvalvular atrial fibrillation (nvaf) exclusion criteria: * patients with anemia (hemoglobin\<100g/l), known human immunodeficiency virus infection, female patients who were pregnant or lactating and patients for whom warfarin was contraindicated, were also excluded * patients with calculated creatine clearance vulue\<30ml/min * patients expected to chronically use a non-steroidal anti-inflammatory agent (except for external preparations) and those treated with a strong cytochrome p4503a4 inhibitor (eg, ketoconazole, clarithromycin, or protease inhibitors) or a strong cytochrome p450 3a4 inducer (eg, rifampicin) during the trial
to demonstrate the relative bioavailability of cefzil 250 mg/5 ml cefprozil oral suspension fed conditions

Conditions: Healthy

Summary: to demonstrate the relative bioavailability of cefzil 250 mg/5 ml oral suspension fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antibiotic
efficacy of brooke bond black tea extract on flow mediated dilation in indian males

Conditions: Healthy

Summary: this study examines the effect of 1800 mg/day standardized brooke bond black tea extract, equivalent to 400 mg flavonoids, on flow mediated dilation in healthy indian males.

flow mediated dilation (fmd) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. evidence from prospective studies suggests that fmd is independently inversely associated with cardiovascular events.

Eligibility criteria:
inclusion criteria: * male volunteers aged between \>_30 _\< 50 years of age * body mass index (bmi) of \>_18 and _\< 25.0 kg/m2 * systolic blood pressure \>_140 and \>_100 mmhg and diastolic blood pressure \ 70 mmhg * subjects who consume _\< 2 cups of coffee per day * subjects who drink tea regularly (\>_ 2 cups per day) * apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and pi * no prescribed medical treatment that may affect study parameters as judged by the study physician * subject willing to abstain from alcohol on day before and on the day of assessment * willing to sign the informed consent form exclusion criteria: * smokers and/or tobacco chewers * those who consume regular alcohol (\> 160 ml of alcohol per week) * reported intense sport activities \> 10h/week * participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit

Keywords: black tea flow mediated dilation vascular function india
psilocybin for major depressive disorder

Conditions: Major Depressive Disorder

Summary: the goal of this study is to assess the effectiveness of psilocybin for the treatment of major depressive disorder and potential therapeutic mechanisms. enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.


Eligibility criteria:
inclusion criteria: * currently meeting dsm-v criteria for a major depressive episode of at least mild-moderate severity * aged 18-85 * ability and willingness to attend study visits and complete study assessments exclusion criteria: * presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: ast/alt \> 150, qtc \> 450ms, meld \> 9) * depression deemed secondary to a severe medical condition * recent use of any classical psychedelic drug or mdma * recent use of any interventional psychiatric treatment (including: ect, ketamine, esketamine, tms) * intention to begin any new treatment for depression prior to primary outcome determination * use of any excluded medication * active substance use disorder * presence of any psychiatric condition that may interfere with the safe administration of psilocybin * active suicidal ideation
high flow nasal cannula therapy for childhood osa

Conditions: Obstructive Sleep Apnea

Summary: the main objective of this study is to evaluate the efficacy of high-flow nasal cannula (hfnc) therapy in children with osa. children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe osa requiring cpap therapy will be recruited. in phase 1 study, eligible subject will be recruited for hfnc therapy titration with psg to assess treatment efficacy. after titration, if hfnc therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with hfnc therapy. at baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.

background: obstructive sleep apnoea (osa) is prevalent in school-aged children and is associated with significant morbidities. poor compliance with positive airway pressure therapy remains an issue and leads to suboptimal treatment in children with osa. alternative therapeutic strategy is needed to manage this group of patients more effectively. objective: to evaluate the efficacy of high-flow nasal cannula (hfnc) therapy in children with osa. hypothesis: the investigators hypothesize that hfnc therapy is effective in reducing the severity of osa in children. design: a 2-phase study - phase 1 is a single arm study to evaluate the efficacy of hfnc therapy in children with osa, phase 2 is an intervention period to evaluate the compliance and quality of life with hfnc therapy. subjects: 46 children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe osa requiring cpap therapy. methods: in phase 1 study, eligible subject will be recruited for hfnc therapy titration with psg to assess treatment efficacy. after titration, if hfnc therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with hfnc therapy. at baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained. primary outcome measure: efficacy of the hfnc therapy, as defined by the change in oahi from baseline to that with hfnc therapy. expected results: efficacy data to determine whether hfnc therapy can be an alternative therapy for children with osa.

Eligibility criteria:
inclusion criteria: * diagnosis of moderate-to-severe osa requiring cpap therapy (moderate-to-severe osa is defined as an oahi ≥ 5 events per hour and reported history of habitual snoring of 3 nights or more per week) exclusion criteria: * syndromal diseases; * cranio-facial anomalies; * pathological central apnoea, chronic respiratory failure or neuromuscular disease as they would require bilevel pap; * secondary obesity e.g. prader-willi syndrome, cushing's syndrome; * history of pneumothorax or pneumomediastinum; * prior use of pap or hfnc therapy; * refusal to use non-invasive ventilation.

Keywords: therapy high flow nasal cannula children adolescents
trial of identifying the lung intersegmental plane by iron sucrose injection staining

Conditions: Lung Neoplasm; Segmentectomy;Intersegmental Plane

Summary: this is a protocol to determine the safety and feasibility of using iron sucrose injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.

this is a protocol to determine the safety and feasibility of using iron sucrose injection to identify the lung intersegmental plane. this is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. one of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. the method used to detect the intersegmental plane remains controversial. it is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.

Eligibility criteria:
inclusion criteria: * 18 years ≤age ≤80 years * the patient must be scheduled to undergo segmentectomy or combined subsegmentectomy. * the patient must be willing and able to comply with all study requirements and have understood and signed the informed consent. exclusion criteria: * a known allergy to iron sucrose injection * the patients who have iron overdose or iron utilization barrier intra-operative founding of extensive pigmentation silicosis or extensive carbon deposition in the lung. * patients who have not received segmental resection. * patients who converted to thoracotomy.
resolute integrity us extended length sub-study(ri us xl)

Conditions: Coronary Artery Disease

Summary: prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the resolute integrity stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (rvd) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the extended length study.

the purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm medtronic resolute integrity zotarolimus-eluting coronary stent system. descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.

Eligibility criteria:
general and angiographic inclusion criteria highlights: * acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery * clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * informed consent * patient agrees to comply with specified follow-up evaluations * single target lesion or two target lesions located in separate coronary arteries * de novo lesion(s) in native coronary artery(ies) * target lesion(s) ≤ 35 mm in length * target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm general and angiographic exclusion criteria highlights: * within 7 days of index procedure platelet count \ 700,000 cells/mm³; white blood cell (wbc) count \ 2.5 mg/dl * acute myocardial infarction (mi) within 72 hrs of the intended trial procedure (qwmi or any elevation of creatine kinase-mb (ck-mb) \> lab upper limit of normal) * previous pci of target vessel(s) within 9 months prior to the procedure * planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure * history of stroke or transient ischemic attack (tia) within prior 6 months * participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * inability to comply with required trial antiplatelet regimen * previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * unprotected left main coronary artery disease

Keywords: target lesion revascularization (tlr) target vessel revascularization (tvr) coronary artery disease myocardial infarction (mi) percutaneous coronary intervention (pci) stent thrombosis target lesion failure (tlf)
long term follow up of scars formation and quality of life assessment study

Conditions: Scars Formation; Quality of Life

Summary: in previous study (mw2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by debrase gel dressing (dgd), which is composed of enzymes that dissolve the damaged skin selectively (dgd removes only the damaged skin and not other parts of the skin). the burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury. scars and patients' quality of life from two treatment arms (dgd and soc) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.


Eligibility criteria:
inclusion criteria 1. adults and children who had participated and completed study mw2004-11-02. 2. subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Keywords: qol
high-speed yoga and executive function

Conditions: Executive Dysfunction; Parkinson Disease; Quality of Life

Summary: the purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. it has been shown that yoga can improve balance and movement in those diagnosed with parkinson's disease.

the purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. it has been shown that yoga can improve balance and movement in those diagnosed with parkinson's disease. subjects will be randomly assigned to either the high-speed yoga group or an inactive control group. all subjects will be tested before and after the 16 week training period using tests of balance, cognition and functional movement. the high-speed yoga group will receive yoga sequences lead by a certified yoga instructor during each of the 32 visits to the yoga studio. each session will last one hour and be conducted two times per week. the program will consist of several different balance poses and movements where participants are encouraged to move quickly. participants will also be asked to move in different directions based on colored lines placed on the yoga mat. to ensure a safe environment, several assistants will be present to help participants move into each pose. in addition, several assistive devices such as chairs and yoga blocks will be available if participants chose to use them.

Eligibility criteria:
inclusion criteria: 1. men and women between 50 and 85 years of age (inclusive); 2. diagnosis of parkinson's disease (hoehn and yahr scale i-iii); 3. ability to ambulate with or without an assistive device for at least 50 ft; 4. ability to get up and down from the floor with minimal assistance; 5. ability to provide informed consent; 6. no medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.); 7. a score of 23 or above on the montreal cognitive assessment; 8. not currently participating in yoga more than one time per week; 9. can understand and communicate in english. 10. willing and bale to provide consent. exclusion criteria: 1. existing musculoskeletal injury. 2. severe freezing of gait. 3. enrolled in another yoga or research program. 4. unstable or active major medical illness. 5. answer "yes" to any questions on the par-q or elder par-q. 6. pregnancy

Keywords: exercise therapy
c11-acetate pet/ct in multiple myeloma: added value to f18-fluorodeoxyglucose pet/ct

Conditions: Multiple Myeloma

Summary: positron emission tomography combined with computed tomography using carbon-11 acetate (act pet/ct) may help detect lesions before treatment and evaluate response following therapy in patients with from multiple myeloma (mm). this study aimed to prospectively assess the clinical utility of act pet/ct in mm as compared to the commonly used f18-fluorodeoxyglucose(fdg).


Eligibility criteria:
inclusion criteria: * at least 20 years of age * previously untreated * complete pre-treatment clinical staging including bone marrow examination * written informed consent to participate in the study exclusion criteria: * concurrent active malignant tumor(s) * pregnant or breast feeding women * non-compliant to pet/ct or to mri * marked renal impairment (contraindicated for contrast-enhanced mri)

Keywords: c11-acetate pet/ct multiple myeloma pretreatment staging response assessment
mep and neuromuscular blocker

Conditions: Brain Tumor

Summary: it is important to predict the influence of the neuromuscular blocking agents on the motor evoked potential. investigator will investigate the dose-response relationship between the degree of the neuromuscular blockade and the motor evoked potential in patients undergoing brain tumor surgery using the population approach. investigator will investigate the influence of the other factors such as the impedence, reactance, muscel amount, and age on the motor evoked potential.


Eligibility criteria:
inclusion criteria: 1. patients aged 19 years old or older, with american society of anesthesiologists physical status 1-3, and scheduled for elective brain tumor surgery under the monitoring of the motor evoked potential exclusion criteria: 1. central or peripheral neuromuscular disease 2. sensory or motor nerve disorder 3. allergy to propofol, remifentanil, and rocuronium 4. patients with pacemaker
study to compare palindrome vs. bioflo duramax dialysis catheters

Conditions: Chronic Kidney Disease

Summary: numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. this prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream palindrome catheter versus the newer bioflo duramax catheter. this study will examine outcomes of patients who receive hemodialysis using either the palindrome catheter or the bioflo catheter. patients will be observed and outcomes will be recorded for three to six months. outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.


Eligibility criteria:
inclusion criteria: 1. males and females 18 - 65 years of age; 2. first de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site 3. requiring at least 3 months dialysis catheter usage 4. no clinical or radiographic evidence of superior vena cava (svc) narrowing 5. patent right internal or external jugular vein 6. willing to provide the dialysis center information for f/u 7. no known diagnosis of hypercoagulopathy exclusion criteria: 1. short term catheter usage plan (\< 1 months) 2. no right jugular venous access 3. catheter use for bone marrow transplant or plasmapheresis

Keywords: bioflo duramax catheter dialysis
cbt for social anxiety disorder delivered by school counselors

Conditions: Social Anxiety Disorder

Summary: this 5-year study addresses the unmet needs of adolescents with social phobia through the testing of a 12-week cognitive-behavioral, school-based group intervention delivered by trained school counselors compared to a nonspecific school counseling program. a secondary goal is to provide further examination of the efficacy of the cbt program delivered by school counselors as compared to the same program delivered by psychologists.

the investigators have tested sass, a school-based group cbt intervention for social phobia, and found it to be effective when delivered by psychologists (masia warner et al., 2005; masia warner et al., 2007). the proposed dissemination study extends this work through a controlled trial of sass delivered by school counselors. the investigators will randomize 126 adolescents with social anxiety disorder, ages 14 through 17, to one of 3 treatments: 1) sass delivered by school counselors (sc-sass), 2) sass delivered by psychologists (expert-sass), or 3) a manualized adolescent group counseling program specifically designed for school counselors, called skills for living (sfl). a comprehensive evaluation will include diagnosis, illness severity, scale ratings of social anxiety and depression, clinical global improvement, overall functioning, and school-relevant indices of function. outcomes will be assessed at baseline, mid-point (after 6 weeks of intervention), post-treatment, and 6 months following intervention completion.

Eligibility criteria:
inclusion criteria: 1. diagnosis. dsm-iv primary diagnosis (most severe) of social anxiety disorder (as determined by the adis-pc) 2. age and sex. boys and girls, 14 through 19 years 3. grade. 9th, 10th, 11th, or 12th 4. english speaking. adolescent exclusion criteria: 1. current diagnosis of substance use or conduct disorder 2. concurrent mental disorder of greater severity than social anxiety disorder 3. current psychotic symptoms 4. current suicidal ideation 5. pervasive developmental disorder, or a significant medical disorder (e.g., substantially impairs functioning, school attendance, or the ability to engage in treatment) 6. current psychological or pharmacological treatment